FDA Approves Easy-to-Use HIV Test

People will soon be able to learn before leaving the doctor's office if they're infected with the AIDS virus.

The government on Thursday approved a 20-minute HIV test that AIDS experts say is so easy to use it will greatly cut the number of people who unknowingly carry and spread the disease

It's not the first rapid HIV test. A competing version has been sold since the mid-1990s, but it is so difficult to use that hardly any clinics offer it. Today's routine HIV tests take up to two weeks to provide results — and at least 8,000 people a year who test positive at public clinics never return to get the news.

The new OraQuick test should slash that number — and encourage even more of the almost quarter-million Americans who don't know they're infected to seek testing, federal scientists said Thursday in announcing Food and Drug Administration approval of OraQuick.

This is “a very, very important milestone,” said FDA science chief Dr. Murray Lumpkin.

To use OraQuick, a health worker pricks a person's finger, drops a spot of blood into a vial of developing solution and drops in the sticklike testing device.

The dipstick gives results similar to common pregnancy tests: One reddish line means no HIV. Two reddish lines mean the person may be infected and needs a confirmatory test to be sure.

OraQuick at first will be available only in hospitals and large health clinics because of a law that restricts who can use certain types of medical tests.

But the test is so simple that Health and Human Services Secretary Tommy Thompson urged manufacturer OraSure Technologies Inc. to seek a waiver of that law allowing OraQuick to be sold in far more places — from small doctors' offices to mobile testing vans and maybe even HIV counseling centers staffed by social workers instead of health professionals.

”You don't need a college education to administer the test,” said OraSure chief executive Mike Gausling, who said he has begun the paperwork to seek that waiver.

The company, in partnership with Abbott Laboratories, will begin selling OraQuick around year's end. Gausling wouldn't provide an exact price, but said OraQuick should cost less than the $20 it costs to perform old-fashioned laboratory HIV tests.

OraQuick's speed and simplicity mean not only that people don't have to drum up the courage for two clinic visits, but that those facing emergencies can get immediate answers, said Dr. Anthony Fauci of the National Institutes of Health.

For example, women in labor who weren't checked for HIV earlier in pregnancy could get tested in the delivery room. That would let newborns of infected mothers get anti-HIV medication immediately, in hopes of keeping them free of the virus.

Also, doctors and nurses exposed to the blood of patients who might have HIV could learn right away if that person had put them at risk, so they'd know if they needed HIV-blocking medication.

OraQuick also may help when the government begins offering smallpox vaccine to health workers and others as protection against a possible bioterrorist attack. While such vaccine plans aren't final yet, smallpox inoculations pose life-threatening risks to anyone with the AIDS virus — so a rapid test could prove critical in screening out potential vaccine recipients who didn't know they had HIV, Fauci said.

Studies show OraQuick is 99.6 percent accurate, the FDA said. People who test positive should get an old-fashioned lab test to confirm HIV infection.

Those who test HIV-free using OraQuick might need to check again a month later if they have recently done anything that could expose them to HIV, such as unprotected sex or intravenous drug use, Lumpkin cautioned. That's because OraQuick detects antibodies to HIV, immune system proteins that can take weeks after infection to form.

AIDS experts expect rapid HIV testing to grow quickly. The FDA is believed close to approving an OraSure competitor, MedMira Inc.'s Reveal test. OraSure also plans to seek FDA approval soon to use OraQuick to test a swab from a patient's gums instead of blood; OraSure currently sells a lab-based oral HIV test.

AIDS activists have spent the last year pushing FDA to approve the new technology, saying rapid tests could become a standard offering in emergency rooms or homeless shelters — spreading access to HIV testing to populations otherwise missed.

”We're excited about it,” said Ray Daniels of the National Association of People With AIDS. But he cautioned that clinics still must take the time to properly counsel people about the ramifications of HIV testing before administering OraQuick.

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